evaluation of the efficacy and safety of the application of begraft peripheral stent graft system

Conditions: Iliac Artery Stenosis

Summary: the trial will be conducted to evaluate the safety and efficacy of the begraft peripheral stent graft system in interventional revascularisation for subjects with primary iliac artery stenosis and/or occlusive lesions by conducting a multi-centre, randomised controlled clinical study with a bare metal stent system as the control, thus providing a basis for the formal use of the product in china

this study adopts a prospective, multi-centre, randomised controlled trial design, aiming at evaluating the efficacy and safety of the begraft peripheral stent graft system for primary iliac artery stenosis and/or occlusive lesions. a total of 182 subjects are planned to be enrolled, with all consecutively enrolled subjects being randomly assigned to an experimental group (begraft group, n=91) and a control group (bare metal stent group, n=91) in the ratio of 1:1 and respectively treated using the begraft peripheral stent graft system and the bare metal stent system. follow-up visits are carried out for the above-mentioned 182 subjects at baseline, upon discharge from hospital, at 30 days, 6 months, 12 months and then once a year from the 2nd to 5th year following surgery. a doppler ultrasound (dus) examination is carried out when subjects return to hospital at 6 months following surgery, and a ct angiography (cta) examination when returning 12 months following surgery, with telephone follow-ups being conducted at 30 days and then once a year from the 2nd to 5th year following surgery.

Eligibility criteria:
inclusion criteria: * aged ≥18 years old, no restrictions in terms of male or female; * participating in the trial voluntarily, and having signed the informed consent form; * tasc class a, b, c or d lesions of the common iliac artery and/or external iliac artery; * primary iliac atherosclerotic stenosis and/or occlusive lesions; * total length of lesions on the affected side ≤100 mm. exclusion criteria: * expected survival period \<12 months; * pregnant women or those unable to take effective contraceptive measures during the trial; * aneurysms present close to the target lesion; * acute or subacute thrombosis within the target vessel; * previously unobstructed internal iliac artery being blocked (diameter stenosis \<70%) by the stented region; * total occlusive lesions, with the guidewire being unable to return the true lumen in the iliac artery; * severe calcification at the target lesion, with the catheter being unable to pass; * allergic to cobalt-chromium alloy (l605), epfte coating material, carbon coating, contrast agent, antiplatelet agents, anticoagulant drugs or presenting with contraindications; * total occlusion of the superficial femoral artery and deep femoral artery, with there being no outflow tract; * suffering from extensive diffuse disease at the distal end, resulting in poor blood flow in the outflow tract following stent placement; * a history of coagulation disorders; * the subject's mental state making it impossible for them to comprehend the nature, extent and possible consequences of the trial, or having a language barrier making it difficult for the subject to give their informed consent; * poor cooperation or potentially poor compliance with the protocol which may cause deviations during the trial.